KVAJET Tablets 10/10 mg

Adult dose

This medication is taken once daily, regardless of meals. For primary hypercholesterolemia, an initial dose of 10/5 mg once daily is recommended. For patients requiring greater reduction in LDL cholesterol levels, the dose may be adjusted. After initiation of treatment or dose adjustment, lipid levels should be checked after an interval of at least 4 weeks, and the dose can be increased up to a maximum of 10/20 mg per day.

This medication may cause a rare side effect known as rhabdomyolysis, which can lead to serious muscle issues; therefore, if symptoms of muscle pain or weakness occur, the doctor must be informed immediately. Additionally, in patients at high risk of serious myopathy or rhabdomyolysis, such as those with severe infections, hypotension, or who have undergone major surgery, administration of this medication should be temporarily suspended or discontinued. This medication should not be administered to patients with poor liver function or active liver disease. Patients with severely impaired kidney function (creatinine clearance < 30 mL/min) should also avoid this medication. Pregnant women or those who may become pregnant, as well as breastfeeding mothers, should not take this medication. This medication contains lactose; therefore, patients with lactose intolerance or related genetic conditions should not take it. Caution is advised while using this medication in patients with a history of alcohol addiction or liver disease, moderate to severe liver dysfunction, and in elderly patients (70 years and older) due to the heightened risk of myopathy. Furthermore, the risk of muscle damage may increase when used in combination with certain other medications, so inform the doctor or pharmacist if other medications are being taken. Regular liver function tests should be performed while taking this medication, and if any signs of liver damage occur, the healthcare provider must be notified immediately. Symptoms such as muscle pain, cramps, weakness, fatigue, fever, etc., should prompt immediate reporting to the doctor, and if necessary, blood tests should be carried out to check for muscle damage. This medication has not been established for safety and efficacy in children, thus it is not recommended. When administering to elderly patients, careful observation is required to consider the risk of myopathy. In the case of overdose, since there is no specific antidote, treatment should be symptomatic, and liver function and muscle enzyme tests should be conducted. Caution is needed while driving or operating machinery since dizziness may occur during the use of this medication. Lastly, this medication should be stored out of reach of children, and it is recommended not to transfer it to another container for safety.

Serious side effects

Urticaria, angioedema, severe skin reactions (Stevens-Johnson syndrome, DRESS), severe swelling, severe chest tightness, difficulty breathing, severe allergic reactions, jaundice, hepatic toxicity, acute hepatitis, toxic hepatitis, severe neurological symptoms (confusion, seizures, visual disturbances, paralysis), acute renal failure, thrombocytopenia, rhabdomyolysis, myopathy, severe muscle pain, immune-mediated necrotizing myopathy, acute kidney

Mild side effects

• Nasopharyngitis
• arthralgia
• headache
• dizziness
• upper respiratory tract infection
• myalgia
• constipation
• nausea
• abdominal pain
• elevated blood bilirubin

This medication may be sensitive to air and moisture, so it should be stored in a tightly closed container. The recommended storage temperature is between 1 to 30 degrees Celsius (room temperature) to maintain its effectiveness.

Appearance

White to nearly white round film-coated tablets

Package unit

30 tablets/box (10 tablets/PTPX3), 30 tablets/bottle, 100 tablets/bottle